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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K252223
Device Name Alpha Endo Handpiece (Alpha Endo)
Applicant
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Rm. 302, Nanshan Zhiyuan A4, #1001 Xueyuan Ave.,
Changyuan Community, Taoyuan St., Nanshan District
Shenzhen,  CN 518000
Applicant Contact Jinsong Zhou
Correspondent
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Rm. 302, Nanshan Zhiyuan A4, #1001 Xueyuan Ave.,
Changyuan Community, Taoyuan St., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Sara Lai
Regulation Number872.4200
Classification Product Code
EKX  
Date Received07/16/2025
Decision Date 10/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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